Comparative Effects of Using Black Seed and Cumin Seed on BCP of Obese Grade I

Sponsor
Sehat Medical Complex (Other)
Overall Status
Recruiting
CT.gov ID
NCT05770791
Collaborator
(none)
55
1
2
4.1
13.4

Study Details

Study Description

Brief Summary

The goal of this Randomized clinical trial is to compare effectiveness of of using black seed (Nigella sativa) and cumin seed (Cuminum cyminum) on Body composition profile of obese grade

  1. The primary objective of this study is To compare effectiveness of of using black seed (Nigella sativa) and cumin seed (Cuminum cyminum) on Body composition profile of obese grade
  2. Subjects will be given a consent form and after subjects read and sign the informed consent, they would be included in study according to eligibility criteria.
Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Black Seed ( Nigella Sativa)
  • Dietary Supplement: Cumin Seed (Cuminum Cyminum)
Phase 1

Detailed Description

Obesity is a global pandemic that is associated with high morbidity and mortality. Natural herbs are commonly used for weight reduction and appetite suppression. Worldwide data based on 1698 studies has shown that the global prevalence of obesity has increased from 3.2 to 10.8% in men and from 6.4 to 14.9% in women. Meanwhile, herbal products are marketed for their weight-loss properties, such as Nigella sativa which has been used for centuries to treat rheumatoid arthritis, diabetes, and asthma; recently, the anti-obesity characteristics of N. sativa have also been indicated. The antihyperglycemic activity, inhibition of free radical formation, anti-obesity and anti-inflammatory activity of cumin seed extract have also been reported previously.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Comparative Effects of Using Black Seed (Nigella Sativa) and Cumin Seed ( Cuminum Cyminum) on Body Composition Profile of Obese Grade I
Actual Study Start Date :
Jan 27, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A

Group A Obese Grade I

Dietary Supplement: Black Seed ( Nigella Sativa)
Intervention will be given once a day for 1 month, total 30 days Data will be collected at baseline and at the end of the intervention at 30th day

Active Comparator: Group B

Group B Obese Grade I

Dietary Supplement: Cumin Seed (Cuminum Cyminum)
Intervention will be given once a day for 1 month, total 30 days Data will be collected at baseline and at the end of the intervention at 30th day

Outcome Measures

Primary Outcome Measures

  1. Body Composition Profile [Change from baseline at 30th Day]

    permits a detailed analysis of the body's major structural components like muscle mass, fat, and bone. It is measured in percentage.

Secondary Outcome Measures

  1. BMI [Change from Baseline at 30th Day]

    Body mass index is a value derived from the mass and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m², resulting from mass in kilograms and height in metres

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Subject having BMI between 30 kg/m2 - 34.5 kg/m2
Exclusion Criteria:
  • Subjects having kidney or liver problems

  • Having ulcers in GIT

  • Subjects having hypertension, thyroid, diabetes or cardiovascular disorders

  • Pregnant and lactating mothers

  • Subjects who are using hormonal or anti-obesity medications

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sehat Medical Complex, Lahore Lahore Punjab Pakistan 55201

Sponsors and Collaborators

  • Sehat Medical Complex

Investigators

  • Principal Investigator: Momina Mehmood, University of Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Waseem Javaid, Project Director, Sehat Medical Complex
ClinicalTrials.gov Identifier:
NCT05770791
Other Study ID Numbers:
  • ZaraYameen001-23
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Waseem Javaid, Project Director, Sehat Medical Complex
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2023